A firm that the government says has been importing contaminated papayas since at least 2011 is vehemently denying statements made in an FDA warning, despite evidence that Cavi brand papayas have been linked to several Salmonella outbreaks, including a current one.

The warning letter, sent yesterday by the Food and Drug Administration and posted for the public today, cites numerous times from 2011 through this year when papayas imported by Agroson’s LLC in the Bronx, NY, were linked to outbreaks that sickened hundreds of people.

Leaders from FDA used the warning letter to Agroson’s as a case in point yesterday when they announced stepped up enforcement of food safety laws, starting with the papaya industry in general because of what FDA’s top two food administrators described as “recurring” outbreak problems.

The FDA announcement yesterday from Acting Commissioner Ned Sharpless and Deputy Commissioner for Food Policy and Response Frank Yiannas was accompanied by a letter putting the entire papaya industry on notice, with preventive steps outlined for the entire supply chain from growers to retailers.

importer says there’s no problem
Agroson’s says their operation has not done anything wrong in its importing, sales and distribution process. A statement attributed to “a spokesperson from the Davidson Law Group” repeatedly denies any wrongdoing.

The Agroson’s statement says the company is willing to pursue legal action regarding the situation.

“We are aware of the recent FDA claims regarding our Cavi brand Papayas and their alleged link to a Salmonella outbreak in June, most recently in a letter issued today. While we respect the FDA’s process and concern for public safety, we are confident that our Cavi brand Papayas are safe for consumption and are not contaminated at this time,” according to the statement from the Davidson Law Group on behalf of Agroson.

“. . . Any claims that we violated the Federal Food, Drug, and Cosmetic Act in our operations is patently false. In fact, repeated, direct testing conducted by the FDA has shown no trace of bacteria in our product. FDA continues to sample our shipments and release it into the U.S. for sale, finding no positive sample to Salmonella. FDA’s epidemiological and traceback evidence is tenuous and insufficient to establish a causal link to the outbreak.

“. . . We will be filing a response to the FDA’s letter within the next week and plan to continue defending ourselves and our brand vigorously, in court if need be.”

The Argoson statement also says when Cavi papayas were lab-confirmed to be contaminated with Salmonella, the company removed the fruit from the stream of commerce. The company did not initiate a recall, according to the FDA. The agency issued a public warning.

FDA warning letter details ‘significant’ problems
In the warning letter to Argoson’s owner Andres Lopez, FDA officials gave a glimpse of the problems at the importer’s operation saying the letter is a summary.”

The problems as detailed in the warning letter include:

“This Warning Letter summarizes evidence that your firm engaged in a pattern of importing or offering for import adulterated food that presented a threat of serious adverse health consequences or death to humans or animals.

“… We reviewed the evidence relevant to your firm’s involvement in importing or offering for import papayas that were implicated in multistate outbreaks of Salmonella or that tested positive for Salmonella. That evidence included but was not limited to the following.

“1. Your firm imported papayas implicated in a multistate outbreak of Salmonella in 2019. Epidemiologic data as documented by the CDC, combined with traceback information gathered by the FDA, support the conclusion that whole fresh papayas distributed by Agroson’s LLC were the source of this multistate outbreak of Salmonella infections.  A summary of the evidence we used to make this determination is as follows.

“As of July 5, 2019, a total of 71 people from 8 states have been infected with outbreak strains of Salmonella Uganda.  Of 26 people interviewed, 20 (77%) reported eating papaya in the week before their illness. CDC states that this proportion is significantly higher than results from a survey of healthy people in which 13% of healthy Hispanics reported eating papayas in the months of January through June in the week before they were interviewed.  

“CDC included over 100 foods in their National Hypothesis Generating Questionnaire and the only food exposure that was significantly correlated to the outbreak of Salmonella Uganda was papaya. . . .

“FDA conducted a traceback investigation for several case individuals that represented various clusters and were able to keep a good history of the food they ate. The ill people reported thirteen points of service (POS) as the source or likely source of their whole fresh papaya exposures. The thirteen POS represent five different retail stores.  The five different retail stores were included in the traceback, and records show four of the five retail stores received whole fresh papaya from Agroson’s LLC.  

“Additionally, Cavi brand papayas were documented as being present at the fifth retail store.  During the outbreak investigation, epidemiologic and traceback analyses of records and information supplied by firms along the distribution chain identified your firm as the supplier and distributor of whole, fresh papayas that were the most likely source of reported cases of salmonellosis.

“FDA asked your firm, the exclusive distributor of this brand, to conduct a voluntary recall of Cavi brand papayas. However, your firm refused to initiate a recall. In order to protect consumers, FDA contacted your wholesale customers to ensure the fruit was no longer available for sale, had been discarded, or not further processed or frozen, and 

“FDA released a public notice to consumers not to consume, sell or distribute Agroson’s Cavi brand papaya. In response to FDA’s July 5th public notice implicating the Cavi brand papayas in the outbreak, your firm sent a letter to multiple customers stating that FDA’s statements were not factual and should be retracted.  Additionally, your firm posted on its public Facebook page that FDA’s assertion that your papayas are the source of the recent Salmonella illnesses is false.

“2. Your firm imported papayas implicated in a multistate outbreak of Salmonella in 2017 and offered for import papayas that tested positive for Salmonella and matched clinical isolates that were associated with an outbreak cluster.

“In June of 2017, FDA, CDC, and public health and regulatory officials investigated a multi-state outbreak of Salmonella infections linked to imported papayas from four farms in Mexico. CDC reported a total of 251 people that were infected with the outbreak strains of Salmonella Thompson (144), Kiambu (54), Anatum (20), Agona (12), Gaminara (7), Urbana (7), Newport & Infantis (4), and Senftenberg (3), from 25 states. Seventy-nine ill people were hospitalized, and two deaths were reported.

“Epidemiologic, traceback and laboratory evidence indicated that papayas produced by Carica de Campeche and imported to the United States by multiple entities were the source of Salmonella Kiambu, Thompson, Agona, Senftenberg, and Gaminara illnesses, affecting 220 confirmed cases included in the main outbreak cluster associated with this outbreak. Agroson’s LLC was one of the entities that imported product from Carica de Campeche. . . .

“Isolates originating from papayas from Carica de Campeche were linked to the main outbreak cluster genetically, and this relationship was confirmed by the FDA traceback investigation. Papayas originating from Carica de Campeche were recalled by Agroson’s LLC and two other firms.

“Additionally, on August 4, 2017, a papaya shipment that your firm imported from El Zapotanito was sampled, and it was confirmed positive with Salmonella Urbana. The isolate from this sample matched clinical isolates that were associated with an outbreak cluster of (7) seven cases. Although this shipment was refused and did not reach consumers, your firm imported adulterated product.

“3. Your firm offered for import papayas that were contaminated with Salmonella in 2011.

“On July 9, 2011, and July 14, 2011, your firm imported two shipments of papaya that were sampled while in import status and were both found positive for Salmonella.  Although these shipments were refused and did not reach consumers, your firm imported adulterated product.”